Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment

Last updated: December 1, 2024
Sponsor: Katarina Hedin
Overall Status: Active - Recruiting

Phase

4

Condition

Throat And Tonsil Infections

Pharyngitis

Treatment

No antibiotic treatment

Phenoxymethylpenicillin

Clinical Study ID

NCT04083417
2019-000756-34
  • Ages > 15
  • All Genders

Study Summary

Sore throat is the second most common cause of antibiotic prescribing in primary care in Sweden. Guidelines for sore throat focus on identifying people with sore throat where there are 3 and 4 specified criteria and where near patient tests identify group A streptococci (GAS). In these cases, phenoxymethylpenicillin is recommended.

Studies that have identified microorganisms in sore throat show that there are other bacteria and viruses than GAS, that give similar symptoms and that sometimes no microorganism is trapped despite pronounced symptoms. In recent years, a bacterium F. necrophorum has been identified, which is found in increased incidence of sore throat, but it is also found in healthy individuals. In clinical practice, many patients are treated with penicillin even if GAS is not captured. This may be because the doctor perceives the patient as sick or because other bacteria are not caught with a near patient test which causes the doctor to treat anyway.

The specific aims are to in patients with GAS-negative sore throat and 3 and 4 criteria, aged 15 years and older in primary care, study whether phenoxymethylpenicillin treatment shortens the duration of the disease, reduces the symptom intensity and sickness absence, and investigates the importance of other microorganisms than GAS in sore throat.

The study is a randomized controlled trial in which patients with sore throat are randomized to phenoxymethylpenicillin 3 times daily for 10 days or to no antibiotic therapy. There will also be and a reference group with severe (Centor score 3-4), GAS-positive acute tonsillitis.

Blood samples for inflammatory and immunological response to infections are taken. Throat samples for culture of F. necrophorum and streptococcal groups C and G, as well as polymerase chain reaction (PCR) analysis for bacteria and viruses are also taken at inclusion and at follow-up.

The outcome will be followed in a patient diary for 10 days and at a return visit after 18-24 days where the clinical outcome is asked for and where the blood- and throat samples are repeated.

Follow-up will also takes place via e-mail after 1 and 3 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

' Centor score 3-4: absence of cough, anamnestic fever (temperature >38.5°C), tender cervical lymphadenitis, and tonsillar exudates (one or both tonsils)

  • Duration of symptoms < 8 days

  • Rapid antigen detection test for GAS taken and negative

  • Willing and able to give informed consent. Subjects under 18 years of age must inaddition have the consent from both parents/caretakers

Exclusion

Exclusion Criteria:

  • Ongoing antibiotic treatment

  • Known or suspected allergies to phenoxymethylpenicillin

  • Suspicion of peritonsillar abscess or indication for admittance.

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: No antibiotic treatment
Phase: 4
Study Start date:
September 09, 2019
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Vårdcentralen Rosenhälsan

    Jönköping, 551 85
    Sweden

    Active - Recruiting

  • Vårdcentralen Kärna

    Linköping, 586 62
    Sweden

    Active - Recruiting

  • Vårdcentralen Lundbergsgatan

    Malmö, 217 51
    Sweden

    Active - Recruiting

  • Mariehems hälsocentral

    Umeå, 906 51
    Sweden

    Site Not Available

  • Ålidhems hälsocentral

    Umeå, 907 36
    Sweden

    Site Not Available

  • Vårdcentralen Skärvet

    Växjö, 352 36
    Sweden

    Active - Recruiting

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